【生物製劑治療外商原廠】RA Specialist (LSO_834)

專注於高品質學名藥與製劑研發，並嚴格遵循國際製藥規範。秉持「品質、安全、創新」的核心理念，持續提升製程技術與品質管理標準，致力於提供穩定、可靠且具臨床價值的醫藥產品，與醫療夥伴共同守護全民健康。

1. Minimum Master's degree in biotechnology, pharmaceuticals, or appropriate relevant scientific or healthcare environment. PharmD or PhD highly preferred. RAC optional.

2. Must have 1-2 years direct experience in Drug Regulatory Affairs

3. FDA and TFDA submission/approvals experience; international experience a plus.

4. Flexible, adaptable, and capable of working well under pressure; Ability to work independently in a fast-paced environment

(1) Be responsible for the registration dossier preparation and submission of assigned projects; Be responsible for timely order the registration sample, dossier, certificates etc.

(2) Locally responsible for PV to fulfill the Deputy Safety Officer role.

(3) Contribute to the discussion of registration plan with both local and global team.

(4) Track the registration status in TFDA and timely report to the line manager.

(5) Organize to answer technical questions referred by TFDA.

(6) Communicate with HQ about the issues related to the responsible product registration; for example, dealing with relative issues on drug quality test in TFDA lab.

(7) Review and press releases of promotional materials and labeling.

(8) Monitor regulation changes and report timely.

(9) Ensure regulatory activities comply with internal Code of Conduct and SOPs during routine work.

(10) Cross functions/Department supporting.

(11) Other tasks that may be assigned by RA &PV manager.